Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New diabetes drug rongliflozin tested in patients with kidney problems

NCT ID NCT05374343

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early study tested a single dose of the drug rongliflozin in 32 Chinese adults with type 2 diabetes who had normal, mildly, or moderately reduced kidney function. Researchers measured how the drug moved through the body and how it affected blood sugar and urine glucose. The goal was to see if kidney function changes how the drug works, which could guide future dosing.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
rongliflozin (a drug taken by mouth)
What this could lead to
If successful, this could help doctors understand how rongliflozin works in people with type 2 diabetes and kidney problems, potentially leading to better blood sugar control.
What could go wrong
This is a very early (Phase 1) study with only 32 people, so results may not apply to everyone. The drug may not work as well in those with kidney impairment, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

32 people

The number who actually took part.

Started

May 2022

Finished

Aug 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Type 2 diabetes patients. * The subject is willing to take effective contraceptive measures without a pregnancy plan within 4 weeks after signing the informed consent form to taking the test drug. * When screening, 19.0 kg/m2 \< or = body mass index (BMI) \< or = 35.0 kg/m2. * No hypoglycemic drugs have been used in the 4 weeks before the baseline period, or stable doses of hypoglycemic drugs are being used. * No medications for other comorbidities or stable medication regimens within 4 weeks before the baseline period. * In the screening period, 6.5% \< or = glycosylated hemoglobin \< or =11.0%, and fasting blood glucose \< or = 13.9 mmol/L. * Glomerular filtration rate (eGFR) \> or = 90 mL/min/1.73m2 estimated according to the modified dietary trial for kidney disease (MDRD) formula (only applicable to patients with type 2 diabetes with normal renal function). * Accompanied by mild or moderate renal impairment, the eGFR calculated according to the MDRD formula meets the following criteria: mild renal impairment: 60\~89 mL/min/1.73m2, moderate renal impairment: 30\~59 mL/min/ 1.73m2 (only for patients with type 2 diabetes with impaired renal function). * Accompanied by mild or moderate renal impairment, accompanied by stable disease in the first 3 months of the baseline period (only applicable to patients with type 2 diabetes with renal impairment). Exclusion Criteria: * Known allergy to sodium-glucose cotransporter 2 (SGLT2) inhibitor drugs or related excipients. * In the 3 months before screening, those who smoked more than 5 cigarettes per day on average or who could not give up smoking from signing informed consent to leaving the group. * Have a history of alcoholism. * Ingested any food or drink containing caffeine, xanthine, alcohol, grapefruit within 48 hours before taking the test drug. * Those who donate blood or lose a lot of blood (\>400 mL) within 3 months before taking the test drug, or have a history of blood transfusion within 1 month before screening, or plan to donate blood within 1 month after the end of the trial. * Those who have taken the trial drug or such drugs within 1 month before taking the trial drug, or participated in the clinical trial of any drug or medical device within 3 months before screening. * Those who have a positive urine drug screen or have a history of drug abuse or drug use in the past 5 years. * The subject is breastfeeding or the serum pregnancy test result is positive. * Subjects had undergone surgery within 1 month before screening, or major surgery was planned during the study period. * Have severe mental illness or language barrier, unwilling or unable to fully understand and cooperate. * History or evidence of other diseases, such as history of repeated urinary tract infections, poorly controlled high blood pressure, type I diabetes, urinary incontinence, etc. * Abnormal laboratory tests, such as a) Alanine transaminase (ALT)/Aspartate aminotransferase (AST)\>2.0×UNL and/or total bilirubin\>1.5×UNL; b) hemoglobin \<100 g/L; c) hepatitis B surface antigen positive, hepatitis C antibody positive, HIV antibody positive , Syphilis antibody positive. * The researcher believes that the subject has any situation that may interfere with the interpretation of the pharmacokinetics, efficacy and safety data of this study. * Subjects considered by the researcher to be unsuitable to participate in this trial.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Type 2 diabetes are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Ping Feng

    Chengdu, Sichuan, 610041, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.